Cumberland Pharmaceuticals Inc. announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of Vibativ(R) (telavancin) injection in children 2 to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) as well as complicated skin and skin structure infections (cSSSIs) caused by certain gram-positive bacteria in adults. This is the first reported study evaluating Vibativ in pediatric patients.

This publication describes results of an open-label study aimed at characterizing a single 10 mg/kg dose of Vibativ in children 2 to 17 years the treatment of a known or suspected bacterial infection. Of the 22 patients treated in the study, 14 were 12 to 17 years of age, 7 were 6 to 11 years of age and one was 2 years of age. Abo Vibabativ (telavancin) for Injection Vibativ is a patented, FDA-appved injectable anti-infective e for the treatment of certain serious bacterial infections including hospital-acquired and ventILator-associated bacterial pneumonia and complicated skin and skin structure infections.

It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin.

The company develops, acquires, and commercializes brands for the hospital acute care, gastroenterology and rheumatology market segments. The company's portfolio of FDA-approved brands includes: Acetadotete(R) (acetylcysteine) injection, for the treatment of pain and fever; Caldoloror(R) (ibuprofen) injection, for the treatment the treatment of pain and fever. Sancuso(R) (granisetron) transdermal system, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol(R) (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ(R).

Vibativ(R") (telavancin) injections, for the treatment of certain serious bacteria infections including hospital-acqu acquired and ventilator-associated bacteria in adults. euvolemic hyponatremIA; and Vibativ®? (telavancin") injection, for the treatment of certain severe bacterial infections including hospital-acquires and ventilator- associated bacterial pneumonia, as well as complicated skin and Skin structure infections.

e company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidates.